A Phase II Study to Assess Acute Toxicity and Quality of Life of Patients With Carcinoma of the Anal Canal Receiving Chemotherapy and Radiation Using Helical Tomotherapy

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00754078

Enrollment

Registered

2008-09-17

Start date

2008-09-30

Completion date

2016-10-31

Last updated

2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Canal Cancer

Keywords

tomotherapy

Brief summary

The hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head.

Detailed description

This is a phase II study using tomotherapy for radiation treatment delivery along with concurrent 5-FU/mitomycin C for the treatment of T2-T4 cancer of the anal canal. They hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head. This is expected to limit or reduce treatment related toxicity and hence prevent or reduce treatment breaks. This may result in delivery of radical treatment with better local control and treatment outcome than using the current radiation treatment technique at our center.

Interventions

RADIATIONTomotherapy

30 fractions of tomotherapy treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient should have histologically proven primary squamous carcinoma or its variant * No history of prior malignancy. * Patients must be free of metastatic disease out of pelvis at the time of diagnosis * Patients must be at least 18 years of age * Performance status 0, 1 or 2 ECOG * T stage 2-4, Any N, stage MO * Patient should be eligible for concomitant chemotherapy * Informed written consent required to participate

Exclusion criteria

* Prior radiation to pelvis * Pregnant or lactating * prior surgical treatment for anal cancer other than biopsy * prior surgical or chemotherapy treatment for anal cancer * T1 tumours (2cm) or evidence of distant mets * comorbid medical conditions precluding radical treatment at the discretion of oncologist

Design outcomes

Primary

Measure	Time frame
Acute Toxicity and Quality of LIfe	3 months

Secondary

Measure	Time frame
colostomy-free survival and/or overall survival	3 and 5 years
Local Recurrence	3 and 5 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026